MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLINE W/SPHNGD/BAC CAT; CERTAS PLUS W/ BACTISEAL & SG

Catalog Number 828807

Device Problem Migration (4003)

Patient Problem Fall (1848)

Event Date 05/23/2023

Event Type  Injury  

Manufacturer Narrative

The certas valve (id (b)(6)) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.However, the possible root cause for the issue reported by the customer, could be due to the patient fell out of bed and hit the ground on the head where the valve was placed.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

A physician reported a certas valve (id (b)(6)) was implanted via ventricular peritoneal shunt on unknown date with unknown setting.On (b)(6) 2023, the patient fell out of bed and hit the ground on the head where the valve was placed.After that, it was possible to change the set pressure.However, the catheter had come out of the ventricle, and the valve itself had shifted to the ventral side inside the pocket.A surgery was performed to reposition the ventricular catheter and valve on (b)(6) 2023 and it was found that the valve was filled with blood.Therefore, the valve was removed and replaced on (b)(6) 2023.

Manufacturer Narrative

The bactiseal catheter ((b)(6)) was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 8.The valve was visually inspected; no defect was noted.The valve was hydrated.The catheters were irrigated, no occlusion noted.The valve passed the test for programming, occlusion, reflux, leak, siphon guard and pressure.Root cause- no root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer, could be due to the patient fell out of bed and hit the ground on the head where the valve was placed.

Event Description

N/a.

• Brand Name: CERTAS INLINE W/SPHNGD/BAC CAT
• Type of Device: CERTAS PLUS W/ BACTISEAL & SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17100903
• MDR Text Key: 317031936
• Report Number: 3013886523-2023-00179
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K143111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1